29 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
FDA 510(k)
FDA Class 2
·Cardiovascular
MODULAR FLEXIBLE REAMER HEAD, Ø13.0mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665000931·
Precision IE 4K
FDA UDI
STRYKER CORPORATION·07613327416367·
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·November 15, 2010
Micromate Navi+
FDA 510(k)
FDA Class 2
·Radiology
TumorSight Viz
FDA 510(k)
FDA Class 2
·Radiology
INRATIO
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC·Product code GJS·January 24, 2011
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·November 23, 2010
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 30, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 10, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 16, 2011
INRATIO2
FDA Adverse Event
Injury
·BIOSITE INCORPORATED·Product code GJS·July 22, 2010
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·November 9, 2010
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·April 11, 2011
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·January 13, 2011
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·November 3, 2010
INRATIO2
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 7, 2011
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 8, 2010
TAXUS (R) LIBERTÉ (R) LONG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 6, 2011
HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·November 7, 2014